DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of group I, claims 1-12 in the reply filed on 6/5/2026 is acknowledged.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In regards to claim 1, the phrase “arranged in parallel” is vague. It is unclear whether “in parallel” requires the wires to be connected electrically in parallel (as discussed in the disclosure), geometrically in parallel (as depicted in, e.g., Fig. 9), either, or both. The examiner is considering the claim to require the wires to be arranged electrically in parallel, but clarification is respectfully requested.
In regards to claims 2, 8, 11 and 12, “the electrodes” is vague. It is unclear whether the claims merely require “one or more electrodes” (as set forth in claim 1), or whether this limitation is requiring a plurality of electrodes. Clarification is respectfully requested.
The remaining claims are rejected by virtue of their dependency.
Claim Rejections - 35 USC § 102/103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-10 and 12 are rejected under 35 U.S.C. 102(a)(1) and (2) as anticipated by McIntyre et al. (US 2012/0271381, hereinafter “McIntyre”) or, in the alternative, under 35 U.S.C. 103 as obvious over McIntyre in view of Schmidt et al. (US 2020/0338344, hereinafter “Schmidt”).
In regards to claim 1, McIntyre discloses an implantable lead capable of use in a cancer treatment system (par. 0002, “a wide variety of other medical conditions”) comprising:
a lead body (Fig. 3A), the lead body comprising
a proximal end (Fig. 3A, element 30, “proximal end”); and
a distal end (Fig. 3A, element 32, “distal end”);
one or more electric field generating electrodes, wherein the electrodes are disposed along a length of the lead body (Fig. 3A, elements 38, “conducting electrodes”);
a plurality of electrical wires (Fig. 10B, par. 0115, “filars”);
wherein the plurality of electrical wires are disposed within the lead body (e.g., Fig. 10C);
wherein the plurality of electrical wires provide an electrical connection between at least one of the electrodes and the proximal end of the lead body (par. 0099, “a single such wire may extend between each connector electrode 36 and a corresponding conductor electrode 38”); and
wherein at least two of the plurality of electrical wires are arranged in parallel and connected to the same electrode (par. 0099, “if redundancy is required, more than one wire may extend between each such connector and conductor electrode pair, with such wires being electrically coupled one to another”; par. 0128, “two or more filars may be coupled to a same electrode 82 to provide redundancy”; par. 0164, ”[e]ach of these wires may then be electrically coupled to the same set of elements to provide redundancy. For instance, each of the wires of cable 118 may be electrically coupled to a same conducting electrode 38 and a same connector electrode 36 (FIG. 3A)”).
McIntyre does not expressly disclose that the lead is used in a cancer treatment system. However, no pulse generator is recited and “for a cancer treatment system” is recited in the preamble of the claim. Since the intended use recited in the preamble does not appear to limit any structure actually set forth in the body of the claim, the examiner is considering McIntyre’s lead as necessarily capable of this function. See MPEP 2111.02. Alternatively and additionally, McIntyre discloses that the lead is for use in “a wide variety of other medical conditions” (par. 0002), but not explicitly cancer treatment. However, Schmidt in the same field of endeavor of implantable lead therapies teaches providing a lead such as McIntyre’s to an implantable cancer treatment system (e.g., Figs. 9-12) to provide the predictable results of flexibly generating electrical fields at the site of cancerous tumors, thus improving patient outcomes (par. 0045). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify McIntyre by using the lead in a cancer treatment system to provide the predictable results of flexibly generating electrical fields at the site of cancerous tumors, thus improving patient outcomes.
In regards to claim 2, the electrodes comprising:
a proximal end; and
a distal end; and
wherein the plurality of electrical wires arranged in parallel are connected to a middle portion of the electrodes between the proximal end and the distal end (e.g., Figs. 4B and 10C).
In regards to claim 3, a set of the plurality of electrical wires reflecting all wires connected to a particular electrode of the one or more electric field generating electrodes have a resistance of less than 0.4 ohm/cm (par. 0005; since components are in parallel and the total resistance in parallel is less than the resistance of the smallest component, each of McIntyre’s filars have a resistance less than that described in par. 0005).
In regards to claim 4, a set of the plurality of electrical wires reflecting all wires connected to a particular electrode of the one or more electric field generating electrodes have a resistance of less than or equal to 0.2 ohm/cm (par. 0005; since components are in parallel and the total resistance in parallel is less than the resistance of the smallest component, the total of all wires has a resistance less than that described in par. 0005).
In regards to claim 5, the lead further comprises a connection plug, the connection plug comprising a plurality of electrical terminals (par. 0047; proximal portion of lead 34); wherein the connection plug is disposed at the proximal end of the lead body (Fig. 3A); and
wherein the connection plug is in electrical communication with the plurality of electrical wires (par. 0047).
In regards to claim 6, the resistance of the electrical wires arranged in parallel and connected to the same electrode as measured from an electrical terminal to a point of connection with the electrode is less than 5 ohms (par. 0088 and Fig. 7; embodiments include wires with resistance as low as 0.5 ohms).
In regards to claim 7, the resistance of the electrical wires arranged in parallel and connected to the same electrode as measured from an electrical terminal to a point of connection with the electrode is less than or equal to 3.5 ohms (par. 0088 and Fig. 7; embodiments include wires with resistance as low as 0.5 ohms).
In regards to claim 8, the electrodes are disposed circumferentially around the lead body and extend a distance along a longitudinal axis of the lead body (Fig. 3A).
In regards to claim 9, at least three of the plurality of electrical wires are arranged in parallel and connected to the same electrode (par. 0164; up to seven total wires).
In regards to claim 10, the plurality of electrical wires have a diameter of less than 130 microns (par. 0165; 0.00133 inches = 33.782 microns).
In regards to claim 12, the electrodes comprising at least two electrical field generating electrodes (Fig. 3A; pars. 0044, 0051), wherein the at least two electrical field generating electrodes are separated by a distance along a longitudinal axis of the lead body (Fig. 3A).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over McIntyre (or McIntyre and Schmidt) in view of Pianca et al. (US 2012/0197375, hereinafter “Pianca”). McIntyre discloses the essential features of the claimed invention except for wherein the electrodes comprise a flat ribbon of metal, wherein the flat ribbon of metal is wrapped around the lead body. However, Pianca in the same field of endeavor of implantable leads teaches a lead wherein the electrodes comprise a flat ribbon of metal, wherein the flat ribbon of metal is wrapped around the lead body (Figs. 6A-6C, pars. 0091-0096) to provide the predictable results of improved accuracy of electrodes placement (pars. 0004, 0005, 0032). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify McIntyre by providing a lead wherein the electrodes comprise a flat ribbon of metal, wherein the flat ribbon of metal is wrapped around the lead body to provide the predictable results of improved accuracy of electrodes placement.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. As claim 1’s scope appears to include electrode leads with stranded or braided conductors, the prior art is replete with this feature. Pischlar et al. (US 2021/0106838) is another of many examples.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL W KAHELIN whose telephone number is (571)272-8688. The examiner can normally be reached M-F, 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at (571)270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792
Prosecution Insights